The study (LXC2008DH001) was a Phase I clinical study in healthy Chinese adult subjects to evaluate the safety, tolerability, and pharmacokinetics of DH001 after single and multiple oral administration in healthy adult subjects. A total of 63 healthy subjects were enrolled in a double-blind design, of which 51 received single or multiple oral doses of DH001. No dose-limiting toxicity or serious or important adverse events occurred in DH001, demonstrating a good safety and tolerance profile. At the same time, we evaluated the pharmacokinetic parameters of single and multiple doses of DH001 in healthy adult subjects. The results showed that the absorption and utilization of DH001 exceeded expectations, which laid a solid foundation for phase II clinical study.

On adriamycin cardiotoxicity

Adriamycin has been a milestone in the development of medical oncology and has been widely used in clinical practice, but its serious cardiotoxicity has been troubling clinicians and patients. At present, the mechanism of cardiotoxicity caused by adriamycin is still not fully understood. It is generally believed that free radicals generated by adriamycin are one of the main causes of cardiotoxicity, which involves Fe3+ mediated non-enzymatic pathway and glutathione REDOX reaction cycle. Adriamycin produces a large number of free radicals which cannot be metabolized in time, damaging biological macromolecules in cells, such as enzymes and nucleic acids, causing lipid and protein oxidation of cell membranes, leading to changes in myocardial cell structure and function, including diastolic and systolic dysfunction of the heart.

About DH001

DH001 is an effective monomer found in Chinese traditional medicine. It can reduce the incidence and severity of cardiac toxicity caused by adriamycin by improving cardiac function, and is suitable for patients receiving adriamycin treatment. Dr. Zhang Min, President of Mengyang Pharmaceutical, said: The No. 46 "Guidelines for Clinical Value-Oriented Research and Development of Antitumor drugs" issued by the National Center for Pharmaceutical Approval states that the highest goal of new drug research and development should be to provide patients with better (more effective, safer or more convenient) treatment options. At present, malignant tumors show a trend of slow disease, which makes cancer patients have higher expectations for the safety of drugs and long-term quality of life. We are laying out in advance in this field, and more drugs in the field of cancer treatment related diseases will enter clinical studies. The excellent safety and good bioavailability of DH001 in the Phase I clinical study gives us great confidence. We believe that DH001 will bring us greater surprises in the following clinical trials, and look forward to the drug can be launched as soon as possible to relieve the pain of patients.